K-number	K250814
Device name	Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
Applicant	Zeus Scientific
Product code	OBE
Device class	Class II
Decision date	May 8, 2026
Decision	Substantially Equivalent
Regulation	866.5100

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Alegria Flash devices are chemiluminescent immunoassay (CLIA) kits for qualitative or semi-quantitative detection of IgG antibodies to SSA-52, SSA-60, and SSB (La) in human serum. These tests are intended as aids in diagnosing Sjögren's syndrome, systemic lupus erythematosus, systemic sclerosis, polymyositis, and dermatomyositis, and must be performed on the Alegria Flash instrument.

Technological characteristics

Not stated in this summary.

Test standards cited

The document references ISO 13485 clauses for design controls (7.3), nonconforming product (8.3), corrective action (8.5.2), and preventive action (8.5.3) as part of Quality Management System Regulation requirements, but does not cite specific test methods or performance standards for the devices themselves.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

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